Technical Field
[0001] The present invention relates to a guide tube equipped with a balloon for puncture,
which is a tool intended to safely and reliably ensure a route for percutaneous approach
to the inside of a body, and employs, as a target, a balloon which does not immediately
burst when punctured, for example, with a puncture needle, wherein an inner balloon
is formed in such a manner that an endoscope can be inserted into a tube holding the
balloon, and used.
[0002] Conventionally, Percutaneous Endoscopic Gastrostomy (PEG), which is one of endoscopic
surgeries for forming fistulas on the stomach lumen and on the skin surface of the
abdominal wall using an endoscope has been developed in 1979 especially as an enteral
nutrition administration method by a pediatric surgeon, Gaudert and an endoscopic
surgeon, Ponsky (for example, see Patent Document 1), and several procedures based
on this technique have been further developed, and are each spreading widely.
[0003] However, these techniques cannot be used, or are hard to use, in cases such as "cases
of retention of ascites in a large amount" and "cases where the liver or transverse
colon is positioned between the stomach and the abdominal wall" and "anamnestic cases
of stomach surgeries" due to the puncture of the gastric wall/abdominal wall.
Further, as for a method for transnasally placing a tube in the stomach, long-term
placement may increase pains of the nostril, nasal cavity and pharynx and may form
an ulcer in the nostril, thereby making it difficult to maintain the placement, in
some cases. Further, even pneumonia may develop together due to difficulty in expectoration
of sputum, in some cases. Thus, this method is not preferable from these QOL viewpoints.
[0004] On the other hand, a method for forming a cervical esophageal fistula under X-ray
fluoroscopy was developed by Nakano
et al. in 1993. The placement technique employed in this method involves transnasally inserting
a tube equipped with a balloon into the esophagus, injecting a contrast agent into
the balloon at the cervical esophagus to expand the inner cavity of the cervical esophagus,
then percutaneously puncturing the cervical esophagus under X-ray fluoroscopy to form
a cervical esophageal fistula, and placing a nutrition tube therein. This placement
technique is simple, less invasive and less painful to patients, and useful in long-term
nutrition management.
[0005] This method, however, involves puncturing only under X-ray fluoroscopy, and thus
might be risky in view of the anatomical structure of the cervical part. In this method,
while an indwelling bladder foley catheter is used as the tube equipped with a balloon,
it is visually recognized, based on the rupture of the balloon, whether a puncture
needle has reached the inner cavity of the esophagus at the time of puncturing. Therefore,
there was a possibility that the esophagus wall would be damaged by a needle tip end
or that the needle is inserted only into a shallow site and thus would come off from
the esophagus wall, after rupture of the balloon.
[0006] Thus, in 1997, Oishi
et al., who are also inventors of the present invention, have improved the method for forming
a cervical esophageal fistula under X-ray fluoroscopy by Nakano
et al., and then have invented a method for safely and reliably puncturing a balloon with
a puncture needle while confirming the balloon position using an ultrasonic probe
from the outside of the body as a method for puncturing a balloon of a balloon catheter
(for example, see Non-Patent Documents 1 and 2).
[0007] Further, the inventors of the present invention have further improved the above method
for forming a cervical esophageal fistula to form a balloon of a balloon catheter
to be punctured, which does not immediately burst even upon puncture of the balloon,
and also to combine the above method with dedicated introduction tools (for example,
see Patent Document 2) in order to aim at bed-side implementation of the method without
use of an X-ray imaging machine.
Patent Document 1: Japanese Patent Application National Publication (Laid-Open) No.
6-503243
Patent Document 2: International Publication No. WO99/36120
Non-Patent Document 1: Oishi, "Percutaneous/Trans-Cervical Esophageal Gastrostomy, Adaptation and Usefulness
Thereof," Journal of Japan Surgical Society, 1997
Non-Patent Document 2: Oishi, "Percutaneous/Trans-Cervical Esophageal Gastrostomy, Tricks and Sub-Damages
thereof," Journal of Japanese Society of Gastroenterological Surgery, 1997
Disclosure of Invention
Problem to Be Solved by Invention
[0008] The present invention has been made in light of the actual situation of the above-described
guide tube equipped with a balloon for puncture, and an object thereof is to provide
a guide tube equipped with a balloon for puncture, devised to ensure a deeper level
of puncture when the balloon is punctured with a puncture needle, in order to safely
and reliably ensure a route for percutaneous approach to the inside of the body.
Means for Solving Problem
[0009] Namely, the present invention relates to a guide tube equipped with a balloon for
puncture, including a main body tube equipped with a balloon on its tip end-side surface,
the tube having a main lumen for insertion of an endoscope, which penetrates from
the rear end to the tip end, and a sub lumen brought in gas/liquid communication with
the inside of the balloon, the main lumen being provided, at its rear end, with an
endoscope insertion part, and the sub lumen being provided, at its rear end, with
connectors for inflating and contracting operations of the balloon, wherein the balloon
on the tip end-side surface is used as an outer balloon, a needle through hole, through
which a puncture needle sufficiently passes, is formed in a wall surface of the main
body tube located inside the outer balloon, the hole is blocked air-tightly with an
inflatable sheet material, and the sheet material is provided as an inner balloon,
the inner balloon being so formed that, upon inflation of the outer balloon, the inner
balloon inflates and projects from the needle through hole toward the inside of the
main lumen due to the internal pressure of the outer balloon, so that the tip end
of the puncture needle can be pierced into the inflating and projecting part.
[0010]
(2) In the guide tube equipped with a balloon for puncture according to the present
invention, while the outer balloon and the inner balloon are desirably formed of the
same material in the above configuration, the same material is not necessarily used
to form the balloons.
(3) The elongate hole for insertion of the puncture needle desirably has a size of
about 10 mm x 20 mm.
(4) As regards the through hole, it is preferable to provide a marking for identifying
the position of the hole on the outer periphery wall of the main body tube on a line
along the length direction of the main body tube including the hole. The marking may
be provided in either pattern, at the front side of the main body tube or over an
area from the front side to the vicinity of the hole.
(5) Further, a reinforcing pipe is mounted on the inner surface of the main lumen
provided with the elongate hole in the main body tube. The reinforcing pipe is intended
to prevent the deformation or collapse of the lumen provided with the elongate hole
for needle insertion when the outer balloon is inflated.
(6) The balloon for puncture recited in any one of the above items (1) to (4) is characterized in that the outer balloon has the following material properties: a thickness of 0.01 mm to
1 mm, a tensile strength of 8 MPa to 25 MPa, a 100% modulus of 3 MPa to 6 MPa, an
elongation of 300% to 460%, and a balloon internal pressure of 2.8 psi to 75 psi,
and that the inner balloon has material properties which are identical with those
of the outer balloon, or has such material properties that the inner balloon is easier
to inflate than the outer balloon.
(7) The guide tube according to any one of the above items (1) to (5) is characterized in that the main body tube has transparency ensuring visual recognition of the inside of
the outer balloon from the endoscope.
(8) The guide tube according to any one of the above items (1) to (6) is characterized in that a balloon attachment part located at least at the tip end side of the main body tube
is mounted to be arranged inside the balloon with respect to the longitudinal direction
of the outer balloon.
(9) The guide tube according to any one of the above items (1) to (7) is characterized in that the lumen for endoscope insertion is equipped, its rear end, with a membrane-like
seal member having a slit or a hole.
Effect of Invention
[0011] The guide tube equipped with a balloon for puncture according to the present invention
is used so that a puncture needle can be pierced into a balloon more deeply when the
balloon is punctured with the puncture needle. Thus, the guide tube is quite convenient
in safely and reliably forming percutaneous routes for various purposes in all the
hollow organs (such as esophagus, stomach, bile duct, pancreatic duct, intestine,
ureter and bladder).
Best Mode for Carrying Out Invention
[0012] Next, the present invention will be specifically described, with reference to the
drawings.
FIG. 1 is a sectional side view of a conventional guide tube equipped with a balloon
for puncture (hereinafter, simply referred to as the "guide tube"). FIG. 2 is a schematical
view showing a method for using the guide tube shown in FIG. 1. FIG. 3 is a sectional
side view of the guide tube as one Example of the present invention. FIG. 4 is a sectional
side view showing an enlarged tip end of the guide tube as one Example of the present
invention. FIG. 5 is a right-side sectional view of FIG. 4, and FIG. 6 is a flat sectional
view of FIG. 4. FIG. 7 is a sectional side view of an enlarged tip end part, showing
the state where a puncture needle is inserted when the guide tube as one Example of
the present invention is inflated. FIG. 8 is a right-side sectional view of FIG. 7.
[0013] First, one example of conventional endoscope-insertion type guide tubes equipped
with a balloon for puncture will be described with reference to FIGS. 1 and 2. A conventional
guide tube includes a main body tube 1, a balloon 2, a connector 3, a membrane-like
seal part 4 for endoscope insertion, a main lumen 5 for endoscope insertion, a sub
lumen 6 and a balloon attachment part 7, as shown in FIG. 1.
[0014] The main body tube 1 shown in FIG. 1 is a thin tube having one or more inner cavities.
One of the inner cavities is the sub lumen 6 for balloon inflation, of which the tip
end is blocked and has a side hole 6a which opens to a balloon inner cavity. The main
lumen 5 for endoscope insertion is formed to have a thickness approximately equivalent
to that of an endoscope 20 used and an appropriate length, with consideration for
the physical size of a patient, insertion site, and the like. Further, the main body
tube 1 has appropriate flexibility and elasticity at normal room temperature and body
temperature, and the commonly used materials therefor include synthetic resins such
as soft vinyl chloride resins, polyurethane resins and silicone rubbers. In short,
any material can be used so long as the material has such transparency that one can
visually recognize the inside of the balloon by means of the endoscope.
[0015] Next, as one example of methods of using the conventional guide tube described with
reference to FIG. 1, a method for ensuring a percutaneous insertion route from the
cervical part to the esophagus will be described with reference to FIG. 2. As shown
in FIG. 2, the endoscope 20 for the upper digestive organs, bronchial tubes or any
other applications is inserted into the main lumen 5 for endoscope insertion of the
guide tube, and they are orally inserted into a site passing over the entrance part
of the esophagus in the state where the endoscope 20 projects from the tip end of
the guide tube. Then, the guide tube is inserted along the endoscope 20, and, at a
position where the balloon 2 has passed over the entrance part 23 of the esophagus,
physiological saline or the like is injected from the connector 3 preliminarily connected
to a syringe 21 or the like to inflate the balloon 2. Further, the endoscope 20 is
pulled backward to ensure a broad puncture site, and the position of the balloon 2
is confirmed by means of an ultrasonic probe contacted with the cervical part from
the body surface.
[0016] The ultrasonic probe is strongly pushed to establish the state where the thyroid,
trachea, artery, vein and the like are shifted to the right/left side with respect
to the balloon 2, and, in that state, a puncture needle 22 is pierced toward the balloon
2. It is confirmed, in an endoscopic image and an ultrasonic image, that the balloon
2 does not burst or contract at the moment when the balloon is punctured with the
puncture needle 22, and that the tip end of the needle 22 is surely located within
the balloon 2.
[0017] After the above operations, a guide wire (not shown) is inserted in a necessary quantity
from the terminal end of the puncture needle 22 for the removal of the puncture needle
22. While pushing the endoscope 20 and balloon 2 for puncture and directing the guide
wire toward the stomach side, the puncture needle 20 is detached from the inside of
the balloon 2. The physiological saline or the like within the balloon 2 is sucked
by means of the syringe 21 to cause this balloon 2 to contract, and the endoscope
20 is pulled back to the upper part of the esophagus. A dilator with a sheath (not
shown) is inserted from the terminal end of the guide wire to expand the puncture
side, with visual recognition by means of the endoscope 20. Then, only the dilator
is removed to ensure a route to the inside of the esophagus. By virtue of the thus-ensured
route, an appropriate catheter is subsequently inserted.
[0018] In the conventional guide tube described with reference to FIGS. 1 and 2, when the
balloon 2 is punctured with the puncture needle 22, once the tip end of the needle
22 is contacted with the surface of the sub lumen 6 within the balloon 2 or of the
lumen 5 for endoscope insertion, the needle cannot be pierced any more. Thus, the
puncture depth is shallow and has a limit, and the puncture needle 22 may possibly
come off from the balloon 2.
[0019] Then, according to the present invention, the balloon 2 of the main lumen 5 for endoscope
insertion is used as an outer balloon, and, at a site positioned inside the outer
balloon 2, an elongate hole 10 having a size of about 10 mm x 20 mm has been formed
as a needle through hole through which the puncture needle 22 sufficiently passes,
and an inflatable sheet material capable of blocking this elongate hole 10 air-tightly
has been provided as an inner balloon 9. By virtue of this configuration, when a liquid
is injected from the sub lumen 6 into the outer balloon 2 so that the balloon 2 inflates,
the inner balloon 9 inflates and projects from the elongate hole 10 toward the inside
of the main lumen 5 due to the internal pressure of the balloon (see FIGS. 7 and 8).
As a result of this, when the outer balloon 2 is punctured with the puncture needle
22, the tip end 22a of the puncture needle 22 can pass through the elongate hole 10,
and can be pierced into the inner balloon 9 inflating and projecting to the inside
of the hole 10. Here, the outer balloon 2 does not immediately burst, and firstly
contracts by suction of the liquid within the balloon 2, and thus one can endoscopically
and ultrasonically recognize the state where the tip end 22a of the puncture needle
22 is located within the inflating and projecting inner balloon 9. The puncture needle
22 can be inserted into a deeper site, thereby preventing the needle 22 from coming
off from the outer balloon 2 and ensuring the inner cavity until the outer balloon
2 contracts.
[0020] In the meantime, the tip end of the main body tube 1 is, of course, subjected to
chamfering or the like to improve the insertability of the tube into the body, and
desirably has an obliquely cut shape, not an orthogonally cut shape, though not shown,
in order to improve the insertability.
[0021] Next, a specific example of the guide tube including a main lumen 5 for endoscope
insertion according to the present invention will be described with reference to FIGS.
3 to 7. As illustrated in FIG. 3, the guide tube of the present invention includes
a main body tube 1, a balloon 2, a connector 3, a membrane-like seal part 4, a main
lumen 5 for endoscope insertion, a sub lumen 6, and a balloon attachment part 7. While
the guide tube is similar in this regard to the conventional guide tube shown in FIG.
1, the balloon 2 described above is referred to as an outer balloon in the present
invention.
[0022] The main body tube 1 shown in FIG. 3 is formed of a thin tube, and includes the main
lumen 5 for endoscope insertion which is formed to have forms, such as an inner diameter,
and properties such that an endoscope 20 penetrating from its tip end to its rear
end can be inserted/pulled out, and the sub lumen 6 having a blocked tip end and a
side hole 6a opened to the inner cavity of the outer balloon 2, in which the rear
end of the main body tube 1 communicates with the connector 3 to allow a fluid for
inflation of the balloon to flow in/out of the inner cavity of the balloon 2.
In the meantime, this guide tube is also similar to the previously-described example
also in the chamfered shape, obliquely cut shape and the like of the tip end of the
main body tube 1 shown in FIG. 3 in order to improve the insertability.
[0023] While the main body tube 1 described above is desirably as small in outer diameter
as possible, while ensuring an inner diameter enough to insert the endoscope used,
namely, thin, the main body tube 1 is determined to have an appropriate dimension
to prevent the blocking of the inner cavity caused by bending. Therefore, one of desirable
working examples is to use a composite tube as the main body tube 1 and to embed a
resin, a metal mesh or the like therein. The length of the main body tube 1 is arbitrarily
determined depending on the target site. Further, the main body tube 1 has appropriate
flexibility and elasticity at normal room temperature and body temperature. Normally,
synthetic resins such as soft vinyl chloride resins, polyurethane resins and silicone
rubbers are suitably used as the material for forming the main body tube 1, but the
usable materials are not limited thereto in the present invention.
[0024] Next, the outer periphery or inner cavity of the main body tube 1 of the present
invention is also desirably subjected to lubricative treatment, and practical examples
of the treatment include coating of various hydrogels, in addition to fluororesin
coating and kneading of a silicone oil into the material, and collagen, polyvinylpyrrolidone,
polyacrylamide and the like are preferably used as the hydrogels with consideration
for the toxicity to the human body. Methods that can be utilized to fix these substances
onto the main body tube 1 include a method including coating a catheter with these
hydrogels previously prepared as solutions followed by crosslinking with glutaraldehyde,
a method including coating a catheter with monomers of these hydrogels followed by
crosslinking with a polymerization initiator, and a method including coating the main
body tube 1 with a solution of a hydrogel modified with a photoactive crosslinking
agent and then fixing it by light irradiation. Further, the main body tube 1 is desirably
formed of a material having such transparency that one can visually recognize the
inside of the balloon 2 under the endoscope.
[0025] The outer balloon 2 is formed to have a length ranging from 1 cm to 20 cm, an inflation
diameter ranging from 5 mm to 200 mm and a thickness ranging from 0.01 mm to 1 mm
depending on the insertion site. For example, the balloon is formed to have a thickness,
for example, of about 0.1 mm to 0.3 mm to maximally prevent the balloon from being
bulky for intranasal insertion, to have a length of about 3 cm to 10 cm and an inflation
diameter of about 30 mm for the esophagus, and to have a length of about 5 cm to 20
cm and an inflation diameter of about 200 mm for the stomach.
[0026] A synthetic resin having a JIS-A hardness of 20 to 80, a tensile strength of 8 MPa
to 25 MPa, a tear strength of 20 kg/cm to 60 kg/cm, a 100% modulus of 3 MPa to 6 MPa,
an elongation of 300% to 460% and a balloon internal pressure of 2.8 psi to 75 psi
is normally selected as the material for forming the outer balloon 2. Although a soft
vinyl chloride resin, a polyurethane resin, a silicone rubber and the like are suitably
used as the material, the usable materials are not limited thereto. Polyethylene,
polyester, natural rubber latex and the like may be used.
[0027] It should be noted that, when the outer balloon 2 is formed of a silicone rubber,
a natural rubber or the like, there is a possibility that the outer balloon 2 may
burst, due to its elasticity, at the moment when the outer balloon 2 is punctured
with the puncture needle. Therefore, ingenious devices of forming a nylon mesh or
the like on the outer balloon 2 by impregnation or lamination, and coating the front
or back surface or many layers of the balloon 2 with a synthetic resin, may be employed
in some cases, in order to prevent the balloon 2 from bursting as soon as the balloon
2 is punctured with the puncture needle.
[0028] As one example, when the outer balloon 2 for oral insertion into the esophagus is
made of a soft vinyl chloride resin, a material having a hardness of 60, a tensile
strength of 16 MPa, a tear strength of 45 kg/cm, a 100% modulus of 4.5 MPa and an
elongation of about 400% is selected so that the outer balloon 2 is formed to have
a thickness of about 0.1 mm to 0.3 mm and an outer diameter which is about 2/3 of
the desired inflation diameter. Thus, an appropriate internal pressure is attained,
due to which the liquid for inflation of the balloon gradually flows out of a needle
base, without momentary bursting of the outer balloon 2 when the puncture needle is
pierced thereinto and an inner needle is withdrawn, after the inflation of the outer
balloon 2 up to the desired inflation diameter. The outer balloon 2 is molded into
a desired shape by molding means such as blow molding, dip molding, extrusion molding,
compression molding and the like.
[0029] As regards the method for attaching the outer balloon 2, it is desirable to reduce
the protrusion length thereof from the tip end of the endoscope as much as possible,
as described above. At least, the balloon attachment part 7 at the tip end side with
respect to the main body tube 1 is desirably folded back and attached to be arranged
inside this outer balloon 2, and adhesion, welding and other means are selected for
the attachment thereof. This can reduce damages of tissues around the insertion site.
[0030] The endoscope may be inserted into any site so long as the endoscope insertion site
satisfies the insertion operability with the endoscope 20 depending on the selected
material for the main body tube 1. For example, a soft vinyl chloride resin may be
selected as the material for the main body tube 1 to prevent the puncture needle 22
from passing therethrough, and a silicon rubber may be selected as the endoscope insertion
site due to its flexibility. Namely, it is also desirable to select different materials.
[0031] The sub lumen 6 is intended to connect the outer balloon 2 and the connector 3 in
a gas/liquid circulating manner to allow a liquid for inflation/contraction of the
balloon 2 to circulate. The material used for the sub lumen 6 is not especially limited
so long as the material has flexibility and sufficient strength, and a soft vinyl
chloride resin, a polyurethane resin, a silicone rubber and the like are suitably
used.
[0032] In the present invention, a slit-like elongate hole 10 penetrating to the main lumen
5 for endoscope insertion has been provided at a site where the outer balloon 2 is
attached, specifically, within a range enveloped in the outer balloon 2, at the tip
end side of the main body tube 1, and this elongate hole 10 has been air-tightly blocked
with an inflatable sheet material so that this sheet material has been used as an
inner balloon 9. The sheet material shown has a rectangular shape which is larger
than the elongate hole 10. In the present invention, a cylindrical sheet material
covering the entire periphery of the main body tube 1 can also be used as the sheet
material serving as the inner balloon 9. When the cylindrical sheet material is used,
a communication hole which communicates with the side hole 6a at the tip end of the
sub lumen 6 is provided. While the quality and properties of the sheet material used
as the inner balloon 9 are desirably similar to those of the outer balloon 2, the
inner balloon 9 may be formed of a material having such a property that the inner
balloon 9 is easily inflatable as compared with the outer balloon 2. The materials
for the inner balloon 9 are not limited to the examples indicated above. Further,
in the present invention, in order to identify the position (which has the same meaning
as the position on the outer periphery of the main lumen 5 for endoscope insertion)
of the elongate hole 10 over which the inner balloon 9 is provided in the circumferential
direction of the main body tube 1, a marking 11 is provided on a straight line including
the hole 10 in the length direction of the main body tube 1 (or lumen 5). This marking
11 may be positioned either at the front side of the main body tube 1 or over an area
from the front side to the vicinity of the elongate hole 10 (see FIG. 6).
[0033] When a liquid for inflating the outer balloon 2 is injected into the balloon 2 by
means of a cylinder 21 connected via the connector 3 to the rear end of the main body
tube 1 in the state where the inner balloon 9 described above is provided, the outer
balloon 2 inflates outwardly. At this time, the inner balloon 9 to which the internal
pressure of the inflating outer balloon 2 is applied inflates and projects toward
the inside of the main lumen 5 for endoscope insertion from the elongate hole 10 (see
FIG. 7).
In the present invention, in order to identify the position of the part of the inner
balloon 9 inflating and projecting toward the inside of the lumen 5, i.e. , the position
of the elongate hole 10, on the inner periphery of the main body tube 1 (or the lumen
5), a marking 11 is provided on an extension of the elongate hole 10 along the length
direction of the main body tube 1. This marking 11 may be positioned either at the
front side of the main body tube 1 or over an area from the front side to the vicinity
of the elongate hole 10.
[0034] By the above operations, a space where the tip end 22a of the puncture needle 22
can go into the main lumen 5 for endoscope insertion, i.e., the part of the inner
balloon 9 inflating and projecting toward the inside of the lumen 5 is formed inside
the outer balloon 2 facing the inner balloon 9 in an aspect as illustrated in FIGS.
7 and 8.
[0035] Since the present invention adopts such a configuration that the elongate hole 10
is formed in the main body tube 1 positioned inside the outer balloon 2, and that
the hole 10 is blocked with the inner balloon 9, a "cutout" due to the elongate hole
10 would be formed on the "cylindrical cross section" of the main body tube 1. This
"cutout, " due to its "cutout effect, " may possibly cause deformation or collapse
of the cross section of the main body tube 1 when a liquid is injected into the outer
balloon 2 to inflate the balloon 2 and the internal pressure of the balloon 2 is applied
to the entire periphery of the lumen 5.
[0036] Thus, the present invention may sometimes adopt such a configuration that a reinforcing
pipe 8 made of a thin metal or a hard synthetic resin and just fitted to the inner
surface of the main lumen 5 for endoscope insertion formed with the elongate hole
10 is arranged on the inner surface thereof, in order to prevent the above-described
deformation or collapse. Here, the inner surface of the pipe 8 may be arranged to
coincide with the inner surface of the main lumen 5, or may be a pipe 8 made of a
mesh cloth through which the puncture needle 22 cannot pass.
[0037] Here, the connector 3 is connected to the syringe to ensure injection of the liquid
for inflation of the outer balloon 2, and thus must be of luer taper. However, valve
members (for example, one-way valve, two-way valve and three-way valve) and, additionally,
connectors having a lock-type terminal end may optionally be used. Although the materials
for the connector 3 and the valve member are not especially limited, it is effective
to use synthetic resins such as hard vinyl chloride resins, polycarbonate resins and
ABS resins.
[0038] Next, as one example of the method for using the guide tube according to the present
invention described with reference to FIGS. 3 to 8, a method for ensuring a percutaneous
insertion route from the cervical part to the esophagus will be described. This method
is basically identical with the method for using the conventional guide tube (FIG.
1) previously described with reference to FIG. 2.
[0039] As shown in FIG. 2, the endoscope 20 for use in the upper digestive organs, bronchial
tubes or any other applications is inserted into the main lumen 5 for endoscope insertion
of the guide tube, and they are orally inserted into a site passing over the entrance
part of the esophagus in the state where the endoscope 20 is projected from the tip
end of the guide tube. Then, the guide tube is inserted along the endoscope 20, and,
at a position where the outer balloon 2 has passed over the entrance part 23 of the
esophagus, physiological saline or the like is injected from the connector 3 preliminarily
connected to a syringe 21 or the like to inflate the outer balloon 2. Then, the endoscope
20 is pulled backward to ensure a broad puncture site, and the position of the outer
balloon 2 is confirmed by means of an ultrasonic probe contacted with the cervical
part from the body surface.
[0040] The ultrasonic probe is further strongly pushed to establish the state where the
thyroid, trachea, artery, vein and the like are shifted to the right/left side with
respect to the outer balloon 2, and, in that state, a puncture needle 22 is pierced
toward the outer balloon 2. In the piercing of the puncture needle 22, puncture can
be carried out using the marking 11 as an index so that a needle tip 22a is not deviated
from the elongate hole 10. It is confirmed, in an endoscopic image and an ultrasonic
image, that the outer balloon 2 does not burst or contract at the moment when the
outer balloon 2 is punctured with the needle 22, and that the tip end 22a of the needle
22 is surely located within the outer balloon 2.
[0041] At this time, in the guide tube according to the present invention, the space wherein
the puncture needle 22 can enter is formed within the main lumen 5 through the elongate
hole 10 due to the outward inflation of the outer balloon 2 and the inflation and
projection of the inner balloon 9 provided over the elongate hole 10 within the balloon
2. Thus, it is possible to carry out the operation of inserting the puncture needle
22 into a deeper site than ever before. Even if the inner balloon 9 is punctured with
the puncture needle 22, the balloon 9 does not burst at once. Thus, there is no risk
that an endoscopic image or ultrasonic image cannot be taken immediately.
[0042] Then, a guide wire (not shown) is inserted in a necessary quantity from the terminal
end of the puncture needle 22 for the removal of the needle 22. While pushing the
endoscope 20 and outer balloon 2 and directing the guide wire toward the stomach side,
the puncture needle 22 is detached from the inside of the balloon 2. The physiological
saline or the like within the outer balloon 2 is sucked by means of the syringe 21
to cause this outer balloon 2 to contract, and the endoscope 20 is pulled back to
the upper part of the esophagus. A dilator with a sheath (not shown) is inserted from
the terminal end of the guide wire to expand the puncture side, with visual recognition
by means of the endoscope 20. Then, only the dilator is removed to ensure a route
to the inside of the esophagus. By virtue of the thus-ensured route, an appropriate
catheter is subsequently inserted.
[0043] The site where the guide tube of the present invention is used and the method of
such use can safely and reliably ensure a route for percutaneous approach to the inside
of all the hollow organs (such as esophagus, stomach, bile duct, pancreatic duct,
intestine, ureter and bladder), by appropriately changing or selecting the sizes of
and materials for the endoscope 20, outer balloon 2, inner balloon 9 and puncture
needle 22, and, additionally, guide wire, dilator and sheath used, in addition to
the above-described method for forming a route for percutaneous approach from the
cervical part to the esophagus.
[0044] In the meantime, the endoscope is inserted into/pulled out of the main body tube
1 which is a member constituting the guide tube of the present invention, as described
above, and thus the main lumen 5 for endoscope insertion penetrates from its tip end
to its rear end. In the case where the endoscopic operation such as suction is necessary
in the treatment, a membrane-like seal part 4 provided with a slit or hole may sometimes
be mounted at the rear end of the main lumen 5 in order to ensure the degree of a
negative pressure at the tip end side. The hole or slit to be mounted is determined
to have a dimension slightly smaller than that of the endoscope 20, and synthetic
resins such as soft vinyl chloride resins, polyurethane resins and silicone rubbers
are suitably used as the materials therefor. However, the usable materials are not
limited to these examples.
Industrial Availability
[0045] The present invention is as described above, and the inventive guide tube is used,
thereby making it possible to safely and reliability form a percutaneous route in
all the hollow organs (such as esophagus, stomach, bile duct, pancreatic duct, intestine,
ureter and bladder) for various purposes. Further, the procedures, which conventionally
had to be performed with many hands in an operating room or the like because an X-ray
imaging machine was used, is combined with an endoscope and an ultrasonic probe so
that the procedures can be performed by two persons at a bed side.
Especially, an inner balloon has been provided to ensure a large puncture space (penetration
depth of the puncture needle) as compared with that of the conventional balloon for
puncture in the present invention. Thus, the present invention is quite useful in
successfully performing the above bed-side procedures.
Brief Description of Invention
[0046]
FIG. 1 is a sectional side view of a conventional guide tube.
FIG. 2 is a schematical view showing a method for using the guide tube shown in FIG.
1.
FIG. 3 shows a sectional side view of the guide tube as one Example of the present
invention.
FIG. 4 is a sectional side view showing an enlarged tip end of the guide tube as one
Example of the present invention.
FIG. 5 is a right-side sectional view of FIG. 4.
FIG. 6 is a flat sectional view of FIG. 4.
FIG. 7 is a sectional side view of an enlarged tip end part, showing the state where
a balloon is punctured with a puncture needle when the guide tube as one Example of
the present invention is inflated.
FIG. 8 is a right-side sectional view of FIG. 7.
Explanation of Reference Numerals
[0047]
- 1
- Main body tube
- 2
- Outer balloon
- 3
- Connector
- 4
- Membrane-like seal part
- 5
- Main lumen for endoscope insertion
- 6
- Sub lumen
- 7
- Attachment part of outer balloon 2
- 8
- Reinforcing pipe
- 9
- Inner balloon
- 10
- Elongate hole
- 11
- Marking
1. A guide tube equipped with a balloon for puncture, comprising:
a main body tube equipped with a balloon on its tip end-side surface, the tube having:
a main lumen for insertion of an endoscope, which penetrates from the rear end to
the tip end; and
a sub lumen brought in gas/liquid communication with the inside of the balloon,
the main lumen being provided, at its rear end, with an endoscope insertion part,
and
the sub lumen being provided, at its rear end, with connectors for inflating and contracting
operations of the balloon,
wherein the balloon on the tip end-side surface is used as an outer balloon,
a needle through hole, through which a puncture needle sufficiently passes, is formed
in a wall surface of the main body tube located inside the outer balloon,
the hole is blocked air-tightly with an inflatable sheet material, and
the sheet material is provided as an inner balloon, the inner balloon being so formed
that, upon inflation of the outer balloon, the inner balloon inflates and projects
from the needle through hole toward the inside of the main lumen due to the internal
pressure of the outer balloon, so that the tip end of the puncture needle can be pierced
into the inflating and projecting part.
2. The guide tube equipped with a balloon for puncture according to claim 1, wherein
the outer balloon and the inner balloon are formed of the same material.
3. The guide tube equipped with a balloon for puncture according to claim 1 or 2, wherein
the needle through hole is formed into an elongate shape with a size of about 10 mm
x 20 mm.
4. The guide tube equipped with a balloon for puncture according to any one of claims
1 to 3, wherein a reinforcing pipe is mounted on the inner surface of the main lumen
at the site where the needle through hole is provided.
5. The guide tube equipped with a balloon for puncture according to any one of claims
1 to 4, wherein a marking for identifying the position of the hole on the outer periphery
of the lumen is provided on a line along the length direction of the main body tube
including the needle through hole provided in the wall of the main lumen of the main
body tube.
6. The guide tube equipped with a balloon for puncture according to any one of claims
1 to 5, wherein the outer balloon has the following material properties: a thickness
of 0.01 mm to 1 mm, a tensile strength of 8 MPa to 25 MPa, a 100% modulus of 3 MPa
to 6 MPa, an elongation of 300% to 460%, and a balloon internal pressure of 2.8 psi
to 75 psi, and
the inner balloon has material properties which are identical with those of the outer
balloon, or has such material properties that the inner balloon is easier to inflate
than the outer balloon.
7. The guide tube equipped with a balloon for puncture according to any one of claims
1 to 6, wherein the main body tube has transparency ensuring visual recognition of
the inside of the outer balloon from an endoscope.
8. The guide tube equipped with a balloon for puncture according to any one of claims
1 to 7, wherein an outer balloon attachment part located at least at the tip end side
in the main body tube is mounted to be arranged inside the balloon with respect to
the longitudinal direction of the outer balloon.
9. The guide tube equipped with a balloon for puncture according to any one of claims
1 to 8, wherein the endoscope insertion part provided at the rear end in the main
lumen is equipped with a membrane-like seal member with a slit or a hole.